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Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study (CoreDISTp)

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
CoreDISTparticipation
Standard care
Sponsored by
Nordlandssykehuset HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Physiotherapy, neurology, MS nurse, coordination of care, balance, walking, physical activity, employment

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with MS (Mc Donald's criteria), Expanded Disability Status Scale ≤3.5 (no disability-fully ambulatory with moderate disability), ≥18 years, being employed. By these criteria the study will include individuals most accessible for the intervention and who have the best prospects to maintain/improve balance, walking, physical activity and participation in employment.

Exclusion Criteria:

  • Retired, pregnancy at enrolment, exacerbation within two weeks prior to enrolment and other serious conditions compromising balance, walking or work capacity.

Sites / Locations

  • Bodø Municipality
  • Physiotherapy department, Nordlandssykehuset HF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CoreDISTparticipation

Standard care

Arm Description

a) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST focusing on balance, walking and physical activity and conducted in groups of 3-5 individuals with MS and led by a physiotherapist. To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist will take place; followed by c) four weeks of outdoor group based exercises and physical activity led by a physiotherapist, complemented with an evaluation form regarding employment and physical activity.

The control group will receive the usual consultations at the MS-OP clinic including exploration of possibilities for change in balance and walking together with physiotherapist at the MS-OP clinic. The control group will furthermore follow standard care (their usual follow-up) in the municipality.

Outcomes

Primary Outcome Measures

MS Work Difficulties Questionnaire-23
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Six-Minutes Walk Test
Walking distance within six minutes
MS Work Difficulties Questionnaire-23
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Six-Minutes Walk Test
Walking distance within six minutes
MS Work Difficulties Questionnaire-23
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Six-Minutes Walk Test
Walking distance within six minutes

Secondary Outcome Measures

Trunk Impairment Scale Norwegian Version
Dynamic sitting balance, 6 items, top score 16.
Mini Balance Evaluation Systems Test
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Force Platform
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Activity monitors outcome 1
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Activity monitors outcome 2
The monitors measure number of steps within 7 days
European Quality of Life 5-Dimension-3 Level
Self-perceived health related quality of life regarding five domains, each with three items, and a Visual Analog Scale (0-100) recording perceived health.
Multiple Sclerosis Walking Scale-12
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Multiple Sclerosis Impact Scale-29
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Weight
Self reported weight by kilogram
Height
Self reported height by centimetre
age
Self reported age by years
Social status
Self reported social status; married, cohabitant, living alone
Type of multiple sclerosis
Self reported main types: relapsing remitting, primary progressive, secondary progressive
Year of diagnosis multiple sclerosis
Self reported by year
Medications
Self reported by type of medications
Expanded disability status scale
Self reported or from journal functional status at last yearly control by a neurologist
Occupation
Self reported
Percentage of work
Self reported percentage of work the previous month
Length of education
Self reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree
Trunk Impairment Scale Norwegian Version
Dynamic sitting balance, 6 items, top score 16.
Mini Balance Evaluation Systems Test
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Force Platform
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Activity monitors outcome 1
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Activity monitors outcome 2
The monitors measure number of steps within 7 days
European Quality of Life 5-Dimension-3 Level
Self-perceived health related quality of life regarding
Multiple Sclerosis Walking Scale-12
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Multiple Sclerosis Impact Scale-29
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Percentage of work
Self reported percentage of work
Trunk Impairment Scale Norwegian Version
Dynamic sitting balance, 6 items, top score 16.
Mini Balance Evaluation Systems Test
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Force Platform
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Activity monitors outcome 1
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Activity monitors outcome 2
The monitors measure number of steps within 7 days
European Quality of Life 5-Dimension-3 Level
Self-perceived health related quality of life regarding
Multiple Sclerosis Walking Scale-12
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Multiple Sclerosis Impact Scale-29
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Percentage of work
Self reported percentage of work

Full Information

First Posted
August 27, 2021
Last Updated
September 15, 2021
Sponsor
Nordlandssykehuset HF
Collaborators
Nord University, Hasselt University, Helse Nord
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1. Study Identification

Unique Protocol Identification Number
NCT05057338
Brief Title
Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study
Acronym
CoreDISTp
Official Title
Innovative Follow-up Across Health Care Levels to Optimize Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordlandssykehuset HF
Collaborators
Nord University, Hasselt University, Helse Nord

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multiple Sclerosis (MS) is a chronic disease affecting young adults. Impaired balance, walking, reduced physical activity and participation in employment are common, however, less integrated in the health care. The researchers have developed a multidisciplinary intervention and pathway delivered across health care levels targeting the promotion of balance, walking, physical activity and participation in employment. The research team will perform a pilot feasibility Randomized Controlled Trial (RCT) and interviews to investigate the feasibility of the new intervention compared to a standard care for individuals with lower levels of disability.
Detailed Description
The study addresses core elements in the health services for individuals with MS, constituting approximately 11000 in Norway. The two-armed pilot feasibility-RCT will be performed across the MS-outpatient (MS-OP) clinic, Nordland Hospital Trust, Bodø (NLSH), and in two surrounding municipalities, including 30 employed participants who will be followed for 10-weeks. The new intervention and pathway, CoreDISTparticipation, builds on GroupCoreDIST, which is previously found effective short and long term compared to standard care. CoreDISTparticipation consists of three phases: a) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST for 60 minutes, 2 times per week supplemented with home exercise programs focusing on balance, walking and physical activity. The participants will have access to exercise programs on videos through an open website at Nord University to digitally support home training. To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist (who leads the group trainings) will take place in phase b; followed by phase c) which include four weeks of outdoor group based exercises and physical activity led by a physiotherapist, for 60 minutes, 2 times per week supplemented with the same home exercise programs as in phase b. Evaluation of employment and physical activity will be conducted using an evaluation form. The control group will receive usual consultations at the MS-OP clinic, as well as a session with a physiotherapist at the MS-OP clinic, exploring possibilities for change in balance and walking. In the municipality the control group will follow standard care (their usual follow-up). The research team will examine feasibility, preliminary between-group differences regarding balance, walking, physical activity level, health related quality of life and barriers in employment, as well as the users' experiences with participation in the CoreDISTparticipation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Physiotherapy, neurology, MS nurse, coordination of care, balance, walking, physical activity, employment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT with two arms: intervention group and control group.
Masking
Outcomes Assessor
Masking Description
Assessor is masked for group allocation
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CoreDISTparticipation
Arm Type
Experimental
Arm Description
a) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST focusing on balance, walking and physical activity and conducted in groups of 3-5 individuals with MS and led by a physiotherapist. To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist will take place; followed by c) four weeks of outdoor group based exercises and physical activity led by a physiotherapist, complemented with an evaluation form regarding employment and physical activity.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
The control group will receive the usual consultations at the MS-OP clinic including exploration of possibilities for change in balance and walking together with physiotherapist at the MS-OP clinic. The control group will furthermore follow standard care (their usual follow-up) in the municipality.
Intervention Type
Behavioral
Intervention Name(s)
CoreDISTparticipation
Intervention Description
CoreDISTparticipation is a thorough intervention that contains coordination of services (physiotherapy, MS-nursing and work adaptations) between the MS-OP clinic and the municipality aiming to improve function, physical activity and employment in individuals with MS.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
The standard care group will follow regular consultations at the MS-outpatient clinic including a session with the physiotherapist. Furthermore, this group will follow usual care in the municipality which might include other forms of physiotherapy or physical activity. These will be registered.
Primary Outcome Measure Information:
Title
MS Work Difficulties Questionnaire-23
Description
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Time Frame
Baseline
Title
Six-Minutes Walk Test
Description
Walking distance within six minutes
Time Frame
Baseline
Title
MS Work Difficulties Questionnaire-23
Description
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Time Frame
5 weeks post-test
Title
Six-Minutes Walk Test
Description
Walking distance within six minutes
Time Frame
5 weeks post-test
Title
MS Work Difficulties Questionnaire-23
Description
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Time Frame
10 week post-test
Title
Six-Minutes Walk Test
Description
Walking distance within six minutes
Time Frame
10 week post-test
Secondary Outcome Measure Information:
Title
Trunk Impairment Scale Norwegian Version
Description
Dynamic sitting balance, 6 items, top score 16.
Time Frame
Baseline
Title
Mini Balance Evaluation Systems Test
Description
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Time Frame
Baseline
Title
Force Platform
Description
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Time Frame
Baseline
Title
Activity monitors outcome 1
Description
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Time Frame
Baseline
Title
Activity monitors outcome 2
Description
The monitors measure number of steps within 7 days
Time Frame
Baseline
Title
European Quality of Life 5-Dimension-3 Level
Description
Self-perceived health related quality of life regarding five domains, each with three items, and a Visual Analog Scale (0-100) recording perceived health.
Time Frame
Baseline
Title
Multiple Sclerosis Walking Scale-12
Description
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Time Frame
Baseline
Title
Multiple Sclerosis Impact Scale-29
Description
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Time Frame
baseline
Title
Weight
Description
Self reported weight by kilogram
Time Frame
baseline
Title
Height
Description
Self reported height by centimetre
Time Frame
baseline
Title
age
Description
Self reported age by years
Time Frame
baseline
Title
Social status
Description
Self reported social status; married, cohabitant, living alone
Time Frame
baseline
Title
Type of multiple sclerosis
Description
Self reported main types: relapsing remitting, primary progressive, secondary progressive
Time Frame
baseline
Title
Year of diagnosis multiple sclerosis
Description
Self reported by year
Time Frame
baseline
Title
Medications
Description
Self reported by type of medications
Time Frame
baseline
Title
Expanded disability status scale
Description
Self reported or from journal functional status at last yearly control by a neurologist
Time Frame
baseline
Title
Occupation
Description
Self reported
Time Frame
baseline
Title
Percentage of work
Description
Self reported percentage of work the previous month
Time Frame
baseline
Title
Length of education
Description
Self reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree
Time Frame
baseline
Title
Trunk Impairment Scale Norwegian Version
Description
Dynamic sitting balance, 6 items, top score 16.
Time Frame
5 weeks post-test
Title
Mini Balance Evaluation Systems Test
Description
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Time Frame
5 weeks post-test
Title
Force Platform
Description
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Time Frame
5 weeks post-test
Title
Activity monitors outcome 1
Description
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Time Frame
5 weeks post-test
Title
Activity monitors outcome 2
Description
The monitors measure number of steps within 7 days
Time Frame
5 weeks post-test
Title
European Quality of Life 5-Dimension-3 Level
Description
Self-perceived health related quality of life regarding
Time Frame
5 weeks post-test
Title
Multiple Sclerosis Walking Scale-12
Description
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Time Frame
5 weeks post-test
Title
Multiple Sclerosis Impact Scale-29
Description
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Time Frame
5 weeks post-test
Title
Percentage of work
Description
Self reported percentage of work
Time Frame
5 weeks post-test
Title
Trunk Impairment Scale Norwegian Version
Description
Dynamic sitting balance, 6 items, top score 16.
Time Frame
10 weeks post-test
Title
Mini Balance Evaluation Systems Test
Description
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Time Frame
10 weeks post-test
Title
Force Platform
Description
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Time Frame
10 weeks post-test
Title
Activity monitors outcome 1
Description
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Time Frame
10 weeks post-test
Title
Activity monitors outcome 2
Description
The monitors measure number of steps within 7 days
Time Frame
10 weeks post-test
Title
European Quality of Life 5-Dimension-3 Level
Description
Self-perceived health related quality of life regarding
Time Frame
10 weeks post-test
Title
Multiple Sclerosis Walking Scale-12
Description
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Time Frame
10 weeks post-test
Title
Multiple Sclerosis Impact Scale-29
Description
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Time Frame
10 weeks post-test
Title
Percentage of work
Description
Self reported percentage of work
Time Frame
10 weeks post-test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with MS (Mc Donald's criteria), Expanded Disability Status Scale ≤3.5 (no disability-fully ambulatory with moderate disability), ≥18 years, being employed. By these criteria the study will include individuals most accessible for the intervention and who have the best prospects to maintain/improve balance, walking, physical activity and participation in employment. Exclusion Criteria: Retired, pregnancy at enrolment, exacerbation within two weeks prior to enrolment and other serious conditions compromising balance, walking or work capacity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter Oien, PhD
Organizational Affiliation
Nordlandssykehuset HF
Official's Role
Study Director
Facility Information:
Facility Name
Bodø Municipality
City
Bodø
Country
Norway
Facility Name
Physiotherapy department, Nordlandssykehuset HF
City
Bodø
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study

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